BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 10684286 · Received October 15, 2020

    Report

    Report Number
    3005580113-2020-00429
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    November 20, 2002
    Report Date
    October 15, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: FGE CATHETER, BILIARY, DIAGNOSTIC.

    Description of Event or Problem · 1

    FAZEL ET AL 2003 ¿DOES A PANCREATIC DUCT STENT PREVENT POST-ERCP PANCREATITIS? A PROSPECTIVE RANDOMIZED STUDY¿. THE STUDY WAS CONDUCTED AT A TERTIARY PANCREATICOBILIARY REFERRAL CENTER OVER A 6-YEAR PERIOD. THE STUDY GROUP CONSISTED OF PATIENTS OVER 18 YEARS OF AGE AT HIGH RISK FOR POST-ERCP PANCREATITIS BECAUSE OF A DIFFICULT CANNULATION, SO MANOMETRY, OR THE PERFORMANCE OF ENDOSCOPIC SPHINCTEROTOMY. PATIENTS WERE RANDOMIZED TO RECEIVE A PD STENT OR NO STENT UPON COMPLETION OF THE ERCP (FIG. 1). THE ENDOPROSTHESIS USED WAS EITHER A 5F NASOPANCREATIC CATHETER (NPC) OR 5F, 2-CM LONG PANCREATIC STENT. THE NPC (WILSON COOK MEDICAL INC., WINSTON-SALEM, N.C.) WAS PLACED ENDOSCOPICALLY OVER A GUIDEWIRE UNDER FLUOROSCOPIC GUIDANCE. IT WAS THEN REROUTED BY MEANS OF THE NARES IN STANDARD FASHION AND CONNECTED TO GRAVITY DRAINAGE. IN PATIENTS IN WHOM PD DRAINAGE WAS ACHIEVED BY PD STENT INSERTION, THE STENT WAS PLACED ENDOSCOPICALLY OVER A GUIDEWIRE UNDER FLUOROSCOPIC GUIDANCE. A 5F, 2-CM LONG, 2 BARBED, GEENEN STENT (WILSON COOK) WAS PLACED WITH THE DISTAL END PROTRUDING 0.5 TO 1 CM INTO THE DUODENUM. THE STENT WAS PLACED AFTER DEEP CANNULATION WAS OBTAINED AND ALL ENDOSCOPIC INTERVENTIONS HAD BEEN COMPLETED. IF THE STENT HAD NOT PASSED SPONTANEOUSLY A SECOND ENDOSCOPY WAS PERFORMED TO REMOVE THE STENT. OF THE 86 PATIENTS ENROLLED, 76 WERE AT HIGH RISK FOR POST-ERCP PANCREATITIS AND WERE RANDOMLY ALLOCATED TO THE PD STENT (NPC OR PD STENT) GROUP AFTER ERCP OR THE NO STENT GROUP (CONTROL GROUP). 36 PATIENTS IN THE STENT GROUP AND 38 PATIENTS IN THE CONTROL GROUP. PATIENTS UNDERGOING PD DRAINAGE WITH A STENT OR NPC HAD A LOWER FREQUENCY OF POST-ERCP PANCREATITIS AS COMPARED WITH THOSE IN THE CONTROL GROUP (5% VS. 27%; P < 0.05) (TABLES 2 AND 3). IN ALL CASES, PANCREATITIS IN THE PD STENT GROUP WAS MILD. THE MEAN DURATION OF HOSPITALIZATION FOR POST-ERCP PANCREATITIS WAS SHORTER IN THE PD STENT GROUP AS COMPARED WITH THE CONTROL GROUP (2.5 DAYS VS. 5.5 DAYS). PANCREATITIS WAS CONSIDERED MILD IF HOSPITALIZATION WAS PROLONGED TO 2 TO 3 DAYS AFTER THE PROCEDURE. POST -ERCP PANCREATITIS WAS ALSO PRESENT IN 2 PATIENTS IN THE GEENEN & NPDS-5 GROUP, HOWEVER IT IS UNKNOWN WHICH DEVICE WAS PLACED. THIS FILE WAS CREATED TO CAPTURE THE POSSIBLE POST -ERCP PANCREATITIS WITH NPDS-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150005 NASAL PANCREATIC DRAINAGE SET FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization